Quality Assurance

**Summary**: The Quality Assurance Associate receives training on the Baylis Quality Management System. They perform investigations and analyses within a well-defined scope and objectives. They may provide quality process guidance in areas which they are assigned to others in the organization. Key Responsibilities: Collect, organize and synthesize to support others in their functional area. Responsible for a quality function such as document control/management, quality documentation review, record control/maintenance (as assigned) Participate in Internal Audits as an auditor Draft documents with guidance from others. Routes documents for review and approval. Comply with the Health & Safety policies of the company and inform management of unsafe workingIndustría médica At Baylis Medical, everyone works with a shared purpose: to improve the lives of people around the world. Named one of Canada's Best Managed Companies, we are a rapidly growing leader in the development, manufacturing and commercialization of innovative medical devices in the field of cardiology. Our focus is on providing physicians; clinically-relevant tools, so that no patient goes untreated. We are expanding to Costa Rica and we are looking for talented individuals, like yourself, to join Baylis Medical and make an impact in the lives of patients. Are you ready to join us?**Requisitos**:**Requirements**: Bachelor's degree Professional certification, such as Six Sigma, Quality Engineer, or Quality Auditor Superb computer competence, including database management Knowledge of quality assurance terminology, methods, and tools Analytical, problem-solving, and decision-making skills Demonstrated knowledge of testing best practices, version control practices and defect management practice. Nice to have skills: Knowledge of FDA, GMP, ISO 13485. General Knowledge on Medical devices' Quality Systems & Quality Assurance approaches. Computer Skills including Office package. Internal Auditor Good communications skills. Problem Solving Thinking. " Can do" approach. Level of English: Advance Commands of English MFG experience a must: At least 1 year of experience in a FDA or ISO controlled industry preferred.